Cervical CancerPhase 2NCT04405349
Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer
A Phase 2 study testing VB10.16 and Atezolizumab in people with Cervical Cancer and Cervix Cancer, run by Nykode Therapeutics ASA at 21 sites in 6 countries.
Trial summary
This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervix Cancer
- What is being tested?
- VB10.16 and Atezolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 1 Jul 2020to 24 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has persistent, recurrent, or metastatic non-resectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix, who has failed or is not eligible for treatment with systemic chemotherapy, radiotherapy or other standard-of-care anticancer treatment.
- Tumour must be HPV16 positive. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory.
- Must have a biopsy (archived or new) available for PD L1 assessment at Screening.
- Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.
- Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening.
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- Is aged 18 years or older.
- Has life expectancy of at least 6 months in the best judgement of the investigator.
- Is willing and able to sign a written informed consent form.
Who cannot join
- Patients who, in the investigator's opinion, have progressed rapidly on their previous anticancer treatment (e.g., did not achieve any response [CR, PR, or SD]).
- Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before study enrolment) or leptomeningeal spread of disease.
- Has positive serological test for hepatitis C virus (HCV), hepatitis B virus (HBV), surface antigen (HBsAg), positive HBV core antibody. Human immunodeficiency virus (HIV).
- Has other concomitant or prior malignant disease,
- Has an active, known or suspected autoimmune disease.
- Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents for any concurrent condition.
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- Has known allergy to aminoglycosides or kanamycin or any study treatment component.
- Has history of toxic shock syndrome.
- Has history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organising pneumonia, immune enteritis or active pneumonitis.
- Has evidence or history of clinically significant cardiac disease including congestive heart failure
- Has ongoing toxicity from prior therapy
- Has severe infections within 4 weeks prior to study start
- Current participation in a clinical trial
- Has received investigational drug within 30 days before study entry.
- Has received vaccination against infections within 30 days before study entry.
- Has had prior treatment with CD137, anti-PD-1, or anti-PD-L1 therapeutic antibody or other immune checkpoint targeting agents.
- Has known hypersensitivity to any component of the atezolizumab or VB10.16 formulation.
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
Germany5 sites
Universitatsklinikum Augsburg
Augsburg
University Clinic Carl Gustav Carus
Dresden
Universitatsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover
Medizinische Fakulat Mannheim Der Universitat Heidelberg
Heidelberg
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
Hopital de Libramont
Brussels, 1200
Universitair Ziekenhuis Gent (Uz Gent)
Ghent, 9000
Chu Ucl Namur
Namur, 5000
Bulgaria4 sites
Multiprofile Hospital for Active Treatment for Women's Health - Nadezhda Sofia
Sofia, 1330
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski"
Sofia, 1431
Multiprofile Hospital for Active Treatment "Serdika"" EOOD
Sofia, 1527
University Multiprofile Hospital For Active Treatment Sofiamed
Sofia, 1797
Czechia4 sites
Masaryk Memorial Cancer Institute
Brno, 65653
Nemocnice Pardubickeho Kraje Pardubicka Nemocnice
Pardubice, 53203
University Hospital Kralovske Vinohrady
Prague, 10034
Nemocnice Na Bulovce
Prague, 180 81
Poland3 sites
Jagielońskie Centum Innowacji, Centrum Badań Klinicznych JCI
Krakow
Wielkopolskie Centrum Onkologii
Poznan
'Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
Warsaw
About this study
Official title: A Multi-Centre, Open-label Phase 2a Trial of the Combination of VB10.16 and Atezolizumab in Patients With Advanced or Recurrent, Non-resectable HPV 16-Positive Cervical Cancer
This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care.
Read the detailed description
Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period.
Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria.
- Conditions
- Cervical Cancer, Cervix Cancer
- Being tested
- VB10.16, Atezolizumab
- Keywords
- Metastatic, Recurrent
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB10.16Biological
Vaccination
AtezolizumabBiological
Also called Tecentriq
Intravenously infusion
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | VB10.16 vaccinations. 11 intramuscular (i.m.) vaccinations for up to 48 weeks from first vaccination. 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks + Atezolizumab (1200 mg) intravenous (i.v.) infusion every 3 weeks. Receives: Biological: VB10.16; Biological: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
The number and percentage of participants that experience an adverse event (AE
Measured: 48 weeks (1 year follow-up)
Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at any time during the study
ORR as assessed by RECIST v1.1
Measured: 48 weeks (1 year follow-up)
Secondary outcomes (4)
Duration of response (DOR)
Estimate the duration of response (DOR) in patients with advanced cervical cancer
Measured: 48 weeks (1 year follow-up)
Progression-free survival (PFS)
Estimate the Progression-free survival (PFS) in patients with advanced cervical cancer
Measured: 48 weeks (1 year follow-up)
Overall survival (OS)
Overall survival (OS) in patients with advanced cervical cancer
Measured: 48 weeks (1 year follow-up)
Evaluate immunogenicity of VB10.16 in combination with atezolizumab by analysing HPV16 E6/E7-specific cellular immune responses
Systemic T-cell response
Measured: 48 weeks (1 year follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jul 2020
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nykode Therapeutics ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG, Vaccibody AS
- Responsible party
- Sponsor
- Investigators
- Siri Torhaug, MD, Study director, Nykode Therapeutics ASA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405349
- Sponsor's protocol ID
- VB C-02
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2020
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open-label Phase 2a Trial of the Combination of VB10.16 and Atezolizumab in Patients With Advanced or Recurrent, Non-resectable HPV 16-Positive Cervical Cancer
- ClinicalTrials.gov ID
- NCT04405349
- Acronym / sponsor ID
- VB C-02
- Conditions
- Cervical Cancer, Cervix Cancer
- Keywords
- Metastatic, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Nykode Therapeutics ASAIndustry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG, Vaccibody AS
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care.
Detailed description
Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period.
Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Biological: VB10.16, Biological: AtezolizumabVB10.16 vaccinations. 11 intramuscular (i.m.) vaccinations for up to 48 weeks from first vaccination. 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks + Atezolizumab (1200 mg) intravenous (i.v.) infusion every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has persistent, recurrent, or metastatic non-resectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix, who has failed or is not eligible for treatment with systemic chemotherapy, radiotherapy or other standard-of-care anticancer treatment.
- Tumour must be HPV16 positive. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory.
- Must have a biopsy (archived or new) available for PD L1 assessment at Screening.
- Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.
- Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy.
Key exclusion criteria (17 listed)
- Patients who, in the investigator's opinion, have progressed rapidly on their previous anticancer treatment (e.g., did not achieve any response [CR, PR, or SD]).
- Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before study enrolment) or leptomeningeal spread of disease.
- Has positive serological test for hepatitis C virus (HCV), hepatitis B virus (HBV), surface antigen (HBsAg), positive HBV core antibody. Human immunodeficiency virus (HIV).
- Has other concomitant or prior malignant disease,
- Has an active, known or suspected autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB10.16Vaccination | Biological | Combination Therapy |
| AtezolizumabAlso: TecentriqIntravenously infusion | Biological | Combination Therapy |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: 48 weeks (1 year follow-up)
The number and percentage of participants that experience an adverse event (AE
Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at any time during the study
Time frame: 48 weeks (1 year follow-up)
ORR as assessed by RECIST v1.1
4 secondary outcomes
Duration of response (DOR)
Time frame: 48 weeks (1 year follow-up)
Progression-free survival (PFS)
Time frame: 48 weeks (1 year follow-up)
Overall survival (OS)
Time frame: 48 weeks (1 year follow-up)
Evaluate immunogenicity of VB10.16 in combination with atezolizumab by analysing HPV16 E6/E7-specific cellular immune responses
Time frame: 48 weeks (1 year follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siri Torhaug, MD study director
Nykode Therapeutics ASA
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VB10.16 and Atezolizumab in people with Cervical Cancer and Cervix Cancer, run by Nykode Therapeutics ASA at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Belgium, Bulgaria, Czechia, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: 48 weeks (1 year follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.